HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-
Summary
O&M Halyard, Inc. received 510(k) clearance for HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor, a FXX device. Cleared on 2026-03-18.
Details
Source
510(k) Clearance
External ID
K251967
Action Date
2026-03-18
Status
Traditional
Category
device
Product Code
FXX
Product Description
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor. Product code: FXX.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. O&M Halyard, Inc. has received 16 total clearances in our database.
O&M Halyard, Inc. has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does O&M Halyard, Inc. have FDA actions?
O&M Halyard, Inc. has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251967" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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